Study:  Longitudinal study of morbidity and mortality in vasculitis patients

Institution:  Boston Collaborative Drug Surveillance Program, Boston University School of Public Health, Boston, Massachusetts
Award:  $98,641, two-year study

Summary:  Vasculitis is an inflammation of blood vessels which is mistakenly thought to be an attack by the immune system. It can affect any of the body’s blood vessels and be fatal if left untreated.  Most of the vasculitic syndromes respond well to steroid drugs, such as prednisolone, though some may also require treatment with an immunosuppressive drug, such as cyclophosphamide.  Despite this, vasculitis can still lead to organ damage or even death from its effect on blood vessels, flares (new symptoms develop), and treatment side effects.  Thus, reducing risk of undesired outcomes or death in patients living with vasculitis becomes an important treatment goal.

This project will use the UK-based Clinical Practice Research Datalink, which provides de-identified electronic health data for a large primary care population, to identify a vasculitis population (including patients with giant cell arteritis, granulomatosis with polyangiitis, and Polyarteritis nodosa) and a non-vasculitis population with similar age and sex distribution. Then differences in health conditions including heart disease, stroke, diabetes, high cholesterol, high blood pressure, obesity, cancer, etc., will be compared between the vasculitis and non-vasculitis populations.

In addition, the timing of these health conditions in relation to the date of the first vasculitis diagnosis will be investigated to separate those that were present before vasculitis and those that developed post-diagnosis.  This project will also estimate the rates of death at 1, 3, 5 and 10 years of follow-up after the first vasculitis diagnosis and compare them to the corresponding rates in the non-vasculitis population.  All analyses above will also be conducted in different subgroups of age, sex and type of vasculitis.  Finally this project will identify potential risk factors for death using a survival analysis.  This study will improve our understanding of vasculitis-related health problems and lead to better treatment.

Dr. Susan Jick has been in the field of pharmacoepidemiology for over 25 years working with the Boston Collaborative Drug Surveillance Program where she has conducted research in many areas of drug safety.  She has been involved with the use and development of large automated databases including the General Practice Research Database which has become a major resource for conducting drug safety studies and has changed the way these studies are being conducted today.  Her research activities range from the safety of drugs such as oral contraceptives in relation to venous thrombosis, hormone replacement therapy in relation to cancers, antibiotics in relation to various serious health outcomes, and statins in relation to autoimmune diseases and diabetes, to safety of drug use in the first trimester of pregnancy and use of folic acid to prevent neural tube defects. Dr Jick helps to run a workshop on methods in conducting drug safety studies that is held each year, she teaches the drug epidemiology class at BUSPH and she serves as an advisor to doctoral students in epidemiology.